Status update of the Phase III ARAMIS... - Advanced Prostate...

Advanced Prostate Cancer
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Status update of the Phase III ARAMIS clinical trial with darolutamide in patients with non-metastatic castration-resistant prostate cancer


Not sure if someone reported this already since it happened in April. It's good news that Darolutamide will hopefully be approved for at least one indication in the not-too-distant future. I spoke with my doctor about it last week and he said if it has FDA approval, he'll probably be able to get it for me even though I'm metastatic. Hopefully others will be able to get it as well. Hoping it gets approved soon.

The primary completion date of the study is currently September 14, 2018

For comparsion purposes: The SPARTAN trial for Apalutamide had a primary completion date of May 19, 2017 and was FDA approved on Feb. 14, 2018 nine months later.

Here's the article I saw:

4 Replies


It seems that, while less Apalutamide ends up in the brain than does Xtandi, Darolutamide's affect on the brain is "negligible".


in reply to pjoshea13

Apparently, Enzaluatmide and Apalutamide are structurally based on the original bilcalutamide. Darolutamide has a simlar name, but a very different structure. It only minimally crosses the blood-brain barrier, if it does at all.

From what I've read: "Darolutamide has been found to block the activity of all tested/well-known mutant ARs in prostate cancer, including the recently identified clinically-relevant F876L mutation that produces resistance to enzalutamide and apalutamide." Whether that translates into a overall survival beneift has yet to be proven. Here's a discussion on the subject with Judd W. Moul, MD, Duke University Medical Center and Charles J. Ryan, MD, UCSF

One major advantage to darolutamide is that it is atomically different from the other -lutamides. If one looks at wikipedia for the others and compares to daro-lutamide one can see that the backbone, so to speak, differs substantially. This makes me hopeful that it will be more resistant to mutations.

in reply to tarhoosier

Thanks, yes it is structurally different for the others that are based on Bicalutamide. It also does have resistance to the mutated ARs. I think a lot of patients that develop resistance to either Zytiga or Xtandi will want to try it.

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